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FDA 510(k) Applications Submitted by NOBUKO NAKAJIMA
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190433
02/22/2019
cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit
Roche Molecular Systems, Inc.
DEN190016
03/19/2019
cobas vivoDx MRSA
Roche Molecular Systems, Inc.
K071141
04/24/2007
BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402
BD Biosciences
K071143
04/24/2007
BD TRITEST CD3/CD4/CD45, MODEL 340383
BD Biosciences
K081213
04/30/2008
BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010
BD Biosciences
K173887
12/21/2017
cobas CT/NG for use on cobas 6800/8800 systems
Roche Molecular Systems, Inc.
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